XPD12-077: Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation

Categories:

Psychology

Supportive Bone Marrow Transplant Studies

Healthy Volunteers

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

St. Jude patients:

  • Treated with an allogeneic bone marrow or stem cell transplant at St. Jude
  • 8 years of age or older
  • Younger than 21 at time of transplant
  • More than 5 years from date of transplant

Healthy volunteers (comparison group):

  • 8 years of age or older
  • Primarily speaks English
  • No known history of serious illness
  1. Brief Summary

    Advances in pediatric stem cell transplantation (SCT) have resulted in improved survival and prompted increased attention to the potential late side effects of this procedure. Past studies have shown generally stable cognitive (thinking) function in the first five years after transplant, with little evidence of significant problems. However, there has been almost no research done to study long-term cognitive function (more than 5 years after transplant). In this study, researchers will evaluate large number long-term survivors of SCT using measures of intelligence, academic achievement, and specific cognitive functions such as attention, working memory and processing speed.

    Primary Objectives

    • To evaluate the thinking and learning abilities in long-term SCT survivors
    • To evaluate specific abilities, such as attention, memory and speed processing information in long-term SCT survivors
    • To evaluate psychosocial functioning and quality of life in long-term SCT survivors

    Eligibility Criteria

    St. Jude patients

    Inclusion Criteria:

    • Treated with an allogeneic bone marrow or stem cell transplant at St. Jude
    • 8 years of age or older
    • Younger than 21 years at time of transplant
    • More than five years from date of transplant
    • Primarily speaks English
    • Routinely followed in Bone Marrow Transplant outpatient clinic

    Exclusion Criteria:

    • History of central nervous system (CNS) injury/disease predating or unrelated to reason for SCT
    • History of major sensory or motor impairment that would preclude valid cognitive assessment
    • History of transplant for metabolic storage disorder, osteogenesis imperfecta, osteopetrosis, or dyskeratosis congenital
    • Major sensory or motor impairment that would preclude valid cognitive assessment.
    • History of specific CNS disease/ injury (e.g., Down Syndrome, traumatic brain injury). Does not exclude participants with mild cognitive impairments or special educational needs.
    • No previous participation in BMTPE

    Healthy volunteers (comparison group)

    Inclusion Criteria:

    • 8 years or older
    • Primarily speaks English
    • No known history of serious illness
    • Demographic match to a St. Jude stem cell transplant patient

    Study Sites

    St. Jude Children's Research Hospital
    Memphis, Tennessee

  2. About this study

    Medicines and procedures used to treat cancer can help patients survive the disease but may also cause unwanted short- and long-term side effects. In this study, researchers want to learn more about the possible side effects of a common cancer treatment called stem cell transplantation. Stem cell transplants are also known as bone marrow transplants. 

    This study will include two groups: (1) patients who had a stem cell transplant at St. Jude and (2) healthy volunteers, also known as a comparison group. Participants in both groups will answer questions about their quality of life and health behaviors. They will also take some tests to evaluate general intelligence and academic achievement, attention, memory and processing speed. These evaluations will take about 2 ½ hours to complete. Researchers will then compare the responses of St. Jude patients with those of the comparison group.

    Purpose of this clinical trial

    The main goal of this study is to learn about the effects of stem cell transplants on survivors’ thinking, learning abilities and school performance. Researchers also want to evaluate the social and emotional functioning of survivors and their overall quality of life.

    Eligibility overview

    St. Jude patients:

    • Treated with an allogeneic bone marrow or stem cell transplant at St. Jude
    • 8 years of age or older
    • Younger than 21 at time of transplant
    • More than five years from date of transplant

    Healthy volunteers (comparison group):

    • 8 years of age or older
    • Primarily speaks English
    • No known history of serious illness
    • Demographic match for a St. Jude stem cell transplant patient
  3. XPD12-077 Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT01701492
    Trial Start Date October 2012
    Estimated Enrollment 400
    Study Type Observational
    Conditions Pediatric STC or BMT
    Ages 8 years and older
    Principal investigator Sean Phipps, PhD
    Study Sites St. Jude Children’s Research Hospital
    For a consultation or to discuss XPD12-077 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Sean Phipps, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

Healthy Volunteers Contact

Karen Martin-Elbahesh, Study Coordinator
psychstudyB@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.